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Japanese symbols are broken down into three major categories; kanji, ka

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

takana and hiragana. Kanji symbols are the more intricate ones that yo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

are probably used to seeing. Kanji is used to express words only in J

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

panese by representing sounds that make up a word. Japanese Kanji fi

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

d their origins in Chinese kanji. Japanese Kanji can be used on their

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

wn or in conjunction with other kanji and can be a noun or verb or adje

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

tive. They can have multiple meanings and can be used alongside hiraga

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

a.

Hiragana is used primarily to express words native to the Japanese

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

anguage. Hiragana can be used to express vowels.

Katakana is used to

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

epresent foreign words, which could not be expressed using kanji. Kata

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ana can be used to express sounds. Since the Japanese pronunciation of

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

foreign words is frequently different than their native pronunciation,

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

he katakana can represent something that sounds very different to those

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

outside Japan.

Taken together, Japanese and Chinese symbols have becom

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

very popular in western society as artwork, tattoos and decor on house

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

old articles. While most people in the west have no idea of their mean

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ng, their intricate design, especially kanji, is fascinating and appeal

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ng. Accurate translation of Japanese characters becomes necessary thou

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

h, since many an unsuspecting westerner has displayed their new kanji t

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ttoo, only to later find out that it means something entirely different

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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